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toffels is the chief scien- tific officer of Johnson & Johnson and world- wide chairman for the Pharmaceutical Companies of Johnson & Johnson, now called Janssen. He was also the young student-colleague of Dr. Janssen and made a name for himself in the early 1990s lead- ing breakthrough research in HIV drug resistance and drug development, starting on the path Janssen had discovered. Stoffels joined Janssen in 1992, about the same time I last visited the company headquarters in Beerse, Belgium. I had met and interviewed Paul Janssen several years previously, an occasion I shall never forget. Visiting him at his lair in Beerse was a pilgrimage of sorts — to the place that produced more significant new-drug introductions at the time than any other company in the world, by a large margin. Stoffels' story parallels Janssen's in several respects. He entered medicine in much the same way as Janssen, as a young physician-researcher in the Democratic Republic of the Congo, the former Belgian colony in Africa. He came back home to Belgium determined to fight a disease then still widely perceived as a threat only to third-world or minority populations. To that end, he used the basic method he had learned from Paul Janssen: Investigate the chemical interaction of drug molecules with the disease agent. Specifically, in the case of HIV, Stoffels turned to looking at how the virus adapts to drugs that block its replication by inhibiting reverse tran- scriptase. Thus, Stoffels serves as a direct human connection from the original Janssen com- pany to the new Janssen, the large, global J&J; pharma organization he now runs. As did Janssen, Stoffels works alongside a co- chair, now Joaquin Duato, who heads the commercial end of the pharma group as worldwide chairman of Janssen. Stoffels is officially chairman overseeing the R&D;, business development, and global com- mercial strategy for pharmaceuticals, but CSO of all Johnson & Johnson. Also as it was in the original company, it is the R&D; organization that sets the agenda and direction for all subsequent business and commercial activity at the contemporary Janssen group. Yet a meaningful difference also exists: Janssen was still a relatively small, regional company when it joined J&J; more than three decades ago; today, the legacy Stoffels oversees has expanded to include a huge group of global R&D; and commer- cial organizations. DOWN TO BUSINESS The story would be less interesting if Stoffels had simply stayed with Janssen his entire career. Instead, the search for more effective ways to treat HIV infection took him into entrepreneurial territory. In 1994, he cofounded two companies to carry on the quest: Virco, to phenotype all the viral strains found in patients, and Tibotec, to develop new drugs that would defeat drug-resistant strains. Tibotec's name stems from the type of molecules his team at Janssen had thus far tried and failed to move forward, the TIBOs (i.e. tetrahydro-imidazo[4,5,1-jk][1,4]-ben- zodiazepine-2(1H)-one and –thione). Viral resistance to earlier drugs had defeated trials of the first TIBOs tested at Janssen. "I learned from Paul Janssen how fail- ures help you come to the solution," says Stoffels. "As we worked on HIV, the first drug failed, the second drug failed, the third drug failed, and for only one reason — we did not understand yet how the virus behaved in the body. When we started to do experiments in vitro, we learned that the virus, after a few days of exposure to the drugs, became resistant. That gave me the idea that we should start testing patients to see the subsets of HIV they carried." Stoffels began by setting up a diagnos- tic effort at Janssen to find the multi- resistant strains, and eventually the effort produced some drug candidates. After Janssen retired in 1991, however, Stoffels decided to take his research outside of the company, leading to the startup of Tibotec and Virco. The business grew quickly, attracting widespread attention and capi- tal from the start. " We raised a significant amount of money, and in a short time we went from being five people in a garage with an incu- bator and two office tables to a significant biotech company of about 350 people. My business partner, Dr. Rudi Pauwels, was an extremely good basic scientist and biologist, a brilliant guy who did every- thing in the laboratory and discovery, and I did everything in drug development and business." After the FDA observed that the Tibotec- Virco group had the technology for learn- ing about multiresistant HIV strains and finding drugs to fight them, Stoffels says pharma companies and researchers beat a path to its door. "We built a vast network of hospitals and pharmaceutical companies. We also built and investigated a library of more than 10,000 strains of viruses, and we used the resulting knowledge to advise physicians on how to treat patients and companies on how to develop HIV drugs." Tibotec's own discovery and development efforts eventually yielded two new drugs, Prezista (darunavir) in 2006 and Intelence (etravirine) in 2007. PAUL STOFFELS EXPANDS THE JANSSEN LEGACY By W. Koberstein S We organized ourselves very much biotechnology way but completely focused on certain therapeutic areas. in the — P A U L S T O F F E L S EXCLUSIVE LIFE SCIENCE FEATURE leaders LIFESCIENCELEADER.COM MARCH 2014 24 0 3 1 4 _ F e a t u r e _ J J _ F . i n d d 3 0314_Feature_JJ_F.indd 3 2 / 2 0 / 2 0 1 4 4 : 2 1 : 2 9 P M 2/20/2014 4:21:29 PM